Sr. Manager, Quality ProductionChimerix

THIS JOB HAS EXPIRED

Responsible for all quality GMP Compliance activities associated with the commercial scale development of pharmaceuticals through contracted manufacturing organizations.
Must have in depth working knowledge of regulatory compliance requirements (cGMP/GLP/GCP).
Initiate and participate in compliance activities with responsibility to manage and improve the quality systems that impact cGMP compliance within the company.
Detailed reviews of supplier-generated manufacturing plans, records, processes, and reports.
Qualifications:
BA or BS in related field. At least 7 years (BS/BA or MS/MA) or 5 years (PharmD or PhD) of experience in the pharmaceutical industry including at least 3 years of relevant experience (i.e., compliance, quality assurance) or equivalent combination of experience and education, sponsor experience with outsourced GMP suppliers highly preferred.